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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018630
Receipt No. R000021536
Scientific Title The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
Date of disclosure of the study information 2015/08/15
Last modified on 2018/08/12

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Basic information
Public title The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
Acronym The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
Scientific Title The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
Scientific Title:Acronym The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate a new technique to measure pharmacokinetics and immune response in breast cancer patients treated with T-DM1.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics and immune response of T-DM1
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria a) Pathologically confirmed breast cancer
b) HER2-positive by IHC or ISH
c) Locally advanced or metastatic/recurrent breast cancer
d) Any prior treatment
e) 20 y.o. and over
f) ECOG performance status 0-2
g) Adequate interval from prior therapy
h) Interval over 2w from prior radiotherapy
i) Adequate baseline organ and marrow function as defined below:
Platelet count >= 100,000mm3
Hemoglobin >= 7.0g/dL
AST and ALT <= 2.5x ULN
Serum bilirubin <= 1.5 x ULN
j) Baseline left ventricular ejection fraction (LVEF) >= 50% by echocardiography
k) Signed written informed consent
Key exclusion criteria a) Brain metastasis with clinical symptoms
b) Uncontrollable body fluid
c) Concurrent serious disease or condition
Active infection
concurrent serious psychiatric disorder
Ileus, breeding
Uncontrollable angina and mycardial infarction within 3 months, severe heart disease with heart failure
d) pregnant or lactating women
e) Patient considered irrelevant by attending physician for the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Tamura
Organization National Cancer Center Hospital
Division name Breast and Medical Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email ketamura@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Shimomura
Organization National Cancer Center Hospital
Division name Breast and Medical Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email ashimomu@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information One year follow-up after completion of recruitment.

Management information
Registered date
2015 Year 08 Month 10 Day
Last modified on
2018 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021536

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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